#assigningshelflife #expiry #retesting #ICH #Ichq1e #assigningexpiry
In this video, you will get the information on how to assign self-life, expiry date, or retest date to the finished product or to API. As per ICH Q1E guidelines if we have sufficient stability data based on that we can extrapolate the expiry date or re-test date beyond available stability study data based on 6 months of accelerated stability data and available long-term stability data. Explain with examples how to assign stability data in the case of general products that is products with recommended storage conditions below 25 degrees Celsius or 35 degrees Celsius 40 degrees Celsius and how to assign self-life or expiry date or retest date. Also explained how to assign self-life to Products having storage conditions under refrigeration. Extrapolation is not allowed for Frozen products. In case of frozen products self life shall be assigned based on available long-term or real-time stability.
Негізгі бет Assigning Expiry date, Shelf life, retest date
Пікірлер: 5